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Sign in to claim this brandELTECH KLASER SRL
US
Last updated May 30, 2026
What ELTECH KLASER SRL makes
Eltech Klaser SRL manufactures professional musculoskeletal/physical therapy lasers designed for clinical and therapeutic applications. These devices are intended for use in pain management, tissue repair, and inflammation reduction through laser therapy techniques.
The company’s portfolio consists of Class II medical devices, which are regulated under the FDA’s Unique Device Identification (UDI) system. These products are listed in the FDA’s UDI database and comply with applicable U.S. regulatory requirements for laser therapy equipment.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Eltech Klaser SRL manufacture?
Eltech Klaser SRL specializes in professional musculoskeletal/physical therapy lasers. These devices are primarily designed for clinical use in pain management, tissue repair, and reducing inflammation through laser therapy techniques. The company’s focus is on therapeutic applications within this category.
Where is Eltech Klaser SRL based, and what regulatory region does it operate in?
Eltech Klaser SRL is based in the United States. Its devices are regulated under U.S. medical device laws, including compliance with the FDA’s Unique Device Identification (UDI) system, which ensures traceability and transparency in the healthcare supply chain.
Which regulatory registries or databases list Eltech Klaser SRL’s devices?
Eltech Klaser SRL’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry is part of the U.S. regulatory framework for Class II medical devices, ensuring that these products meet applicable safety and performance standards for laser therapy equipment.
How are Eltech Klaser SRL’s devices classified under U.S. regulations?
Eltech Klaser SRL’s devices fall under the classification of Class II medical devices. This classification is determined by the FDA based on the level of risk associated with the device. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, and they are subject to mandatory registration and listing requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 654931570
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| K-Laser | K-Laser Cube Plus 30 | FDA UDI | Class II | Active |
| K-Laser | K-Laser Cube | FDA UDI | Class II | Active |
| K-Laser | Speciale Live Therapy Plus | FDA UDI | Class II | Active |
| K-Laser | Speciale Live Therapy | FDA UDI | Class II | Active |
| K-Laser | K-Laser Cube3 | FDA UDI | Class II | Active |
| K-Laser | K-Laser Cube4 | FDA UDI | Class II | Active |
| K-Laser | K-Laser Cube Performance 30 | FDA UDI | Class II | Active |
| K-Laser | K-Laser Cube4 Performance | FDA UDI | Class II | Active |
| K-Laser | K-Laser Cube2 | FDA UDI | Class II | Active |
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